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FDA 510(k)

Bovie Disposable Bipolar Ablator

K-Number: K152777 · 2016-01-15

ApplicantBovie Medical Corporation
Decision Date2016-01-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Bovie Disposable Bipolar Ablator is a medical device manufactured by Bovie Medical Corporation. It received FDA 510(k) clearance on 2016-01-15 under approval number K152777. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bovie Disposable Bipolar Ablator?

Bovie Disposable Bipolar Ablator is a medical device that received FDA 510(k) clearance on 2016-01-15. It is manufactured by Bovie Medical Corporation. The 510(k) number is K152777.

When was Bovie Disposable Bipolar Ablator approved by the FDA?

Bovie Disposable Bipolar Ablator received FDA 510(k) clearance on 2016-01-15, under approval number K152777.

What company makes Bovie Disposable Bipolar Ablator?

Bovie Disposable Bipolar Ablator is manufactured by Bovie Medical Corporation.

What is the FDA product code for Bovie Disposable Bipolar Ablator?

The FDA product code for Bovie Disposable Bipolar Ablator is GEI.

Other Devices by Bovie Medical Corporation

K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator K170777Bovie J-Plasma Precise FLEX Handpiece K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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